AU2004233677A1 - Method and tool for filtrating specimen using specimen sampling container, and specimen sampling container - Google Patents

Method and tool for filtrating specimen using specimen sampling container, and specimen sampling container Download PDF

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Publication number
AU2004233677A1
AU2004233677A1 AU2004233677A AU2004233677A AU2004233677A1 AU 2004233677 A1 AU2004233677 A1 AU 2004233677A1 AU 2004233677 A AU2004233677 A AU 2004233677A AU 2004233677 A AU2004233677 A AU 2004233677A AU 2004233677 A1 AU2004233677 A1 AU 2004233677A1
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Australia
Prior art keywords
sample
collection part
communication
sample collection
plug member
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Abandoned
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AU2004233677A
Inventor
Hironobu Isogawa
Katsuya Togawa
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Sekisui Chemical Co Ltd
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Sekisui Chemical Co Ltd
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Publication of AU2004233677A1 publication Critical patent/AU2004233677A1/en
Abandoned legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06Fluid handling related problems
    • B01L2200/0684Venting, avoiding backpressure, avoid gas bubbles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0672Integrated piercing tool
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0681Filter
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0403Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0457Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/06Valves, specific forms thereof
    • B01L2400/0677Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/40Concentrating samples
    • G01N1/4077Concentrating samples by other techniques involving separation of suspended solids
    • G01N2001/4088Concentrating samples by other techniques involving separation of suspended solids filtration
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25375Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Description

SPECIFICATION SAMPLE FILTERING METHOD USING SAMPLE COLLECTING CONTAINER, JIG AND SAMPLE COLLECTING CONTAINER 5 FIELD OF THE INVENTION The present invention relates to methods for filtering a sample using a sample collecting container capable of collecting and filtering a liquid sample such as blood, and to sample collecting containers, andmore specifically, to a sample 10 filteringmethodusinga sample collecting container, the sample collecting container being depressurized in advance and filtering a collected sample by pressure difference, a jig and a sample collecting container. 15 BACKGROUND ART Conventionally, a variety of noncentrifugal blood collection tubes have been proposed wherein a blood sample is collected by a vacuum blood collection needle by utilizing reduced pressure in a container and the blood is filtered through 20 a filter member accommodated in the container. Such blood collection tubes are disclosed, for example, in Japanese Unexamined Patent Publication No. 2002-277357, Japanese published Patent No. 3015854, Japanese Unexamined Patent Publication No. 11-290297 (1999), Japanese Unexamined Patent 25 Publication No. 4-20856 (1992) and Japanese Unexamined Patent 1 Publication No. 2001-321365. In a conventional noncentrifugal sample collecting container, a plugmember is piercedwith a vacuum blood collection needle and blood is collected using reduced pressure. Then the 5 collected blood is filtrated through a filter member located in the sample collecting container or combined with the sample collecting container. Inthiscase, the vacuumbloodcollection needle is removed after completion of the blood collection. The collected blood passes through the filter member owing to the 10 reducedpressure remaining in the lower part of the filtermember, namely in the part into which filtrated blood is to be stored. In-brief, blood is filtrated by a pressure difference between upside and downside of the filter member. However, when the pressures of upside and downside of the 15 filtermember reach equilibrium, thedriving force for filtration is cancelled so that the filtration stops. For this reason, in order to promote the filtration, it was conventionally necessary to make the upside of the filter member tobe atmospheric pressure by detaching the plug member above the filter member 20 to generate a pressure difference between downside and upside of the filter member. In this procedure, however, since the plug member of sample collecting container storing a collected blood sample need to be detached, the operator is susceptible to infection by adhesion of blood. In addition, when the plug 25 member is removed from the sample collecting container, the space 2 over the filter member is widely exposed to the exterior to lead a risk of contamination by foreign matters. A sample collecting container disclosed in Japanese Unexamined Patent Publication No. 11-290297 (1999) has such a 5 structure that an inner tube provided with a filter member in a lower part is hermetically inserted into an outer tube, and filtration is promoted by lowering the pressure in a space under the filter member in the outer tube by moving the inner tube in the direction of removing it from the outer tube. In this 10 structure, however, the driving force required for filtration is inadequate only by the pressure difference obtainable by the above operation, so that filtration may possibly stop during the filtration process. In a sample collecting container disclosed in Japanese 15 Unexamined Patent Publication No. 4-20856 (1992), a collection container for collecting a filteredsample, which is sealedwith a plug and depressurized in advance, and a sample collecting container in which blood has been collected are connected via a filter member, and the blood sample in the sample collecting 20 container is allowed to pass through the filter member by the reduced pressure in the collection container for collecting a filtered sample. In this approach, the degree of depressurization in the sample collecting container is relatively higher, however, there is still fear that filtration 25 stops during the filtration process. 3 DISCLOSURE OF THE INVENTION Inconsiderationofthecurrentstateofconventionalarts, it is an object of the present invention to provide a sample 5 filtering method using a sample collecting container, a jig and a sample collecting container, the sample collecting container capable of not only securely completing filtration of a sample such as blood through a filter member using reduced pressure in the container, but also eliminating an operation that may 10 cause infection by blood such as removing a plug member so as to complete the filtration, as well as achieving excellent safety. In a first aspect of the present invention, there is provided a sample filtering method using a sample collecting 15 container including asample collectionpartstoringa collected liquid sample and having an opening; a plug member provided so as to hermetically seal the opening; a filter member provided in the sample collection part, for filtering the sample collected in the sample collection part; and a sample storage part for 20 storing a sample filtered by the filter member, the internal pressure thereof being reduced in advance, wherein after collecting a sample in the sample collection part using a vacuum blood collection needle, the sample is filtered by pressure difference between the sample collection part and the sample 25 storage part, while the internal pressure of the sample 4 collection part is increased by allowing the sample collection part to communicate with the exterior by piercing the plug member with a communication needle having a communication flow channel. Inonespecificaspectofthefirstaspectoftheinvention, 5 the communication needle is a hollow needle. In other specific aspect of the first aspect of the invention, the communication needle has a communication groove formed on its outer surface and the communication groove extends from a needlepoint toward an end opposite to the needlepoint. 10 In a second aspect of the present invention, there is provided a sample collection jig to be used for establishing communication between inside and outside of the a sample collectingcontainersamplecollectingcontainerhaving a sample collection part storing a collected liquid sample and having 15 an opening, and a plug member provided so as to hermetically seal the opening. The jig comprises: a communication needle having a communication flow channel extending from the side of a needlepoint to the other end opposite to the needlepoint; a gripping portion attached to the side of the other end of the 20 communication needle; a skirt portion extending in the axial direction of the communication needle from the gripping portion; and at least one vane provided on the side of the needlepoint of the communication needle. Inonespecificaspectofthesecondaspectoftheinvention, 25 the communication needle is a hollow needle. 5 In other specific aspect of the second aspect of the invention, the communication needle has a communication groove formed on its outer surface and the communication groove extends from a needlepoint toward an end opposite to the needlepoint. 5 In a third aspect of the present invention, there is provided a sample collecting container capable of filtering a liquid sample, comprising: a sample collection part having an opening and storing a collected liquid sample; a plug member provided so as to hermetically seal the opening; a filter member 10 provided in the sample collection part, for filtering the sample collected in the sample collection part; and a sample storage part for storing the sample filtered by the filter member, the sample collection part, the filter member and the sample storage part being hermetically connected with each other, the internal 15 pressureofsamplestoragepartbeingreducedinadvance, wherein the plugmember has a through hole for establishing communication between the sample collection part and the exterior, and the through hole is hermetically sealed by a removable sealing member on the outer surface of the plug member. 20 The above plug member may be pressed into the aforementioned opening, and in such a case, the plug member can be realized by a common plug formed of rubber, elastomer or the like. It is to be noted, however, "plug member" used in the first to the third aspects of the invention is not limited to 25 that having a form to be pressed into an opening insofar as it 6 can hermetically seal the opening. For example, the plugmember may be formed into a closing member from a sheet or a molded material made of a flexible material. Also in the case of a plug member formed from a sheet or the like member, the plug 5 member can be formed with a through hole for allowing communicationbetweenthesamplecollectionpartandtheexterior and the through hole can be hermetically sealed with a removable sealing member on the outer surface of the plug member. Inonespecificaspectofthethirdaspectoftheinvention, 10 the sealing member is a sheet affixed to the outer surface of the plug member so as to cover the outer surface where the through hole of the plug member is open. In other specific aspect of the third aspect of the invention, the sealing member is a plug press-fitted into the 15 through hole. In a fourth aspect of the present invention, there is provided a sample collecting container capable of filtering a liquid sample, comprising: a sample collection part having an opening and storing a collected liquid sample; a plug member 20 pressed into the opening so as to hermetically seal the opening; a filter member provided in the sample collection part, for filtering the sample collected in the sample collection part; and a sample storage part for storing the sample filtered by the filter member, the sample collection part, the filter member 25 and the sample storage part being hermetically connected with 7 each other and the internal pressure ofsamplestorage part being reduced in advance, wherein an open through hole is formed in a part of inner surface of the sample collection part that is in contact with the plug member, and a flow channel is formed 5 in a part of outer surface of the plug member contacting the inner surface of the sample collection part, the flow channel establishing communication between the through hole and the interior of the sample collection part when its circumferential position is brought into coincidence with the through hole. 10 In a fifth aspect of the present invention, there is provided a sample collecting container capable of filtering a liquid sample, comprising: a sample collection part having an opening and storing a collected liquid sample; a plug member provided so as to hermetically seal the opening; a filter member 15 provided in the sample collection part, for filtering the sample collected in the sample collection part; and a sample storage part for storing a sample filtered by the filter member, the sample collection part, the filtermember and the sample storage part being hermetically connected with each other and the 20 internal pressureofsamplestoragepartbeingreducedinadvance, wherein an open through hole is formed in a part of inner surface of the sample collection part that is in contact with the plug member, and a flow channel is formed in the plug member in such a manner that when the plug member is drawn out from the sample 25 collection part while keeping hermetical sealing between the 8 plug member and the inner surface of the sample collection part, one end of the flow channel is opposite to the through hole and the other end of the flow channel is open in the sample collection part. 5 BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic perspective view of a sample collecting container used in a sample filtering method of a first embodiment of the present invention; 10 Fig. 2 is a perspective view of a jig used in a sample filtering method of the first embodiment of the present invention; Fig. 3 is a schematic perspective view for explaining a process of resuming filtration by using the jig shown in Fig. 15 2; Fig. 4 is a schematic perspective view showing the state that the jig is removed from the sample storage part together with the plug member and the sample collection part after completion of filtration following the operation of Fig. 3; 20 Fig. 5 is a perspective view of a jig used in a modified example of the first embodiment; Fig. 6 is a perspective view of a hollow needle used in another modified example of a filtering method of the first embodiment; 25 Fig. 7 isapartiallycutaway front sectionviewofa sample 9 collecting container according to a second embodiment; Fig. 8 is a partially cutaway front section view for explaining a modifiedexample ofthe sample collecting container shown in Fig. 7; 5 Fig. 9 is apartially cutaway front section view of a sample collecting container according to a third embodiment; Fig. 10 is a partially cutaway front section view of a sample collecting container according to a fourth embodiment; Fig. 11 is a partially cutaway front section view of a 10 sample collecting container according to a fifth embodiment; and Figs. 12A and 12B each represent a perspective view of a modified example of a communication needle used in the present invention. 15 BEST MODE FOR CARRYING OUT THE INVENTION The present invention can be more clearly understood from the following concrete embodiments with reference to the attached drawings. 20 Fig. 1 is a perspective view of a sample collecting container used in a sample filtering method according to a first embodiment of the present invention. A sample collecting container 1 has a sample storage part 2 formed of a cylindrical outer ring having a bottom. At an 25 upper end of the sample storage part 2 is formed an opening 2a. 10 In the present embodiment, the sample storage part 2 represents a part that stores a filtered sample. The sample storage part 2 accommodates a sample collection part 3. The sample collection part 3 used herein refers to the part where 5 a sample before filtration is collected. In the present embodiment, the sample collection part 3 is formed of a generally cylindrical inner tube. The sample collection part 3 is formed with an opening 3a at its upper end. The sample collectionpart 3 is also formedwith a sample dropping 10 part 3b for filtering the filtered sample at its lower end. The sample dropping part 3b is formed integrally with the sample collection part 3 so that it projects downward from the bottom surface of the sample collection part 3. The sample dropping part 3b has a hollow channel through 15 which the filtered sample drops. The sample collection part 3 accommodates a filter member 4. The filter member 4 is formed of an appropriate filter material for removing solid substances in the sample. As such a filter material, fiber assembly, microparticles and the like 20 can be exemplified. The sample storage part 2 and the sample collection part 3 can be formed of, for example, a synthetic resin, glass or the like. The openings 2a and 3a of the sample storage part 2 and 25 the sample collection part 3 are hermetically sealed with a plug 11 member5. Specifically, the plugmember 5has agrippingportion 5a, a larger-diameter portion 5b projecting downward from the bottomsurfaceofthegrippingportion 5a, anda smaller-diameter portion 5c having a relatively small diameter and projecting 5 downward from the bottom surface of the larger-diameter portion 5b. The smaller-diameter portion 5c is pressed into the opening 3a of the sample collection part 3, whereby the opening 3a of thesamplecollectionpart 3 ishermeticallysealedandthesample collection part 3 is fixed to the plug member 5. The 10 larger-diameter portion 5b is pressed into the opening 2a of the sample storage part 2, whereby the opening 2a of the sample storage part 2 is hermetically sealed and the sample storage part 2 is fixed to the plug member 5. The interior of the sample storage part 2 is depressurized 15 to a pressure of 1 to 90 kPa in advance. Therefore, when blood is collected as a sample, blood can be collected into the sample collection part 3 using the reduced pressure in the sample collecting container 1 by piercing the plugmember 5withaknownvacuumbloodcollectionneedle. After 20 collecting the blood, the vacuum blood collection needle is removed from the plug member 5. The plug member 5 is formed of an elastomer or rubber, such as styrene-based elastomers, ester-based elastomers, urethane-based elastomers, butyl rubber, halogenated butyl 25 rubber and natural rubber, for example. Therefore, the hole 12 created by piercing with the vacuum blood collection needle is closed after removal of the vacuum blood collection needle, and the depressurized state in the sample collecting container 1 is kept for a certain period of time. More specifically, while 5 thedegreeofdepressurizationinthesamplecollectingcontainer 1 decreases as the time elapses, the internal space of the sample collection part 3 over the filter member 4 is continuously kept at higher pressure than the space under the filter member 4 of the sample storage part 2. 10 Therefore, owing to the remaining pressure in the sample storage part 2, blood is filtered through the filter member 4. As described in the section of related arts, also in this case, filtration stops when the pressures of upside space and downside space of the filter member 4 reach equilibrium in the sample 15 collecting container 1. Inorderto solve this problem, conventionally, filtration was completed by removing the plug member 5 to open the space over the filter member 4 to air, and again giving a pressure difference between the interior of the sample storage part 2 20 andthe space over the filtermember4. Inthis approach, however, it is possible that the operator will come into contact with blood and is infected by it. In contrast to this, according to the filtering method of the present embodiment, a jig 11 illustrated in Fig. 2 is 25 used to establish communication between the internal space of 13 the sample collection part 3 and the atmosphere, whereby a pressure difference is given between the internal space of the sample collection part 3 and the internal space of the sample storage part 2. 5 The jig 11 has apointedhollowneedle 12 as a communication needle. Near the upper end of the hollow needle 12 is attached adisk-shapedgrippingportionl3. Anupperopeningofthehollow needle 12 opens in the top surface of the gripping portion 13. On the lateral sides of the gripping portion 13 are fixed skirts 10 14, 15 extending downward. The skirts 14, 15 are provided for facilitating manual operation of the jig 11. In the vicinity of the tip end of the hollow needle 12, a plurality of vanes 12a, and 12b are provided. The vanes 12a and 12b are designed to have a shape that approaches the hollow 15 needle 12 as they extend to their tip ends, and have latch faces 12al and 12b1 at their upper ends, respectively. Owing to the above shape, the piercing resistance at the time of piercing the plug member 5 with the hollow needle 12 is not so large, and a large through hole is formed in the plug member 5 by the 20 above vanes 12a and 12b. Furthermore, since the latch faces 12al and 12b1 are provided, it is possible to easily remove the plug member 5 and the sample collection part 3 together with the jig 11 from the sample storage part 2 after completion of filtration. More specifically, when the latch faces 12al and 25 12b1 are brought into abutment on the lower surface of the plug 14 member 5, it is possible to securely drawn out the plug member 5 and the sample collection part 3 together with the jig 11 only by drawing out the jig 11 upward. Referring to Fig. 3, a filtering method using the jig 11 5 will be explained. Fig. 3 is a schematic perspective view showing the state that the jig 11 is attached to the sample collecting container 1 intheprogressiveprocessoffiltrationaftercollectingblood in the sample collection part 3 by means of the aforementioned 10 vacuum blood collection needle. As described above, the filtration may possibly stop during the process only by the remaining pressure in the sample collecting container 1. For dealing with this situation, the gripping portion 13 and the skirts 14 and 15 are gripped with a hand, and the plug member 15 5 is pierced with the hollow needle 12 serving as a communication needle when filtration stops. In this case, the hollow needle 12 is positioned so that the tip end of the hollow needle 12 locates above the blood 6 within the sample collection part 3. As a result of this, communicationbetweenthe space in the sample 20 collection part 3 and the atmosphere is established. Consequently, the pressure difference between upside and downside of the filter member 4 increases to allow progression ofthefiltrationagain. Inthismanner, filtrationbythefilter member 4 is securely completed. 25 After completion of the filtration, the jig 11 is gripped 15 with a hand, and the plug member 5 and the sample collection part 3 are drawn out from the sample collecting container 1 together with the jig 11 (see Fig. 4). In this manner, it is possible to obtain the sample storage part 2 storing a filtered 5 sample. The sample storage part 2 can be directly subjected to an automatic analyzer or the filtered sample in the sample storage part 2 may be collected by a dropper, a pipette or the like. Asdescribedabove, intheabovefilteringmethodaccording 10 to the present embodiment, when filtration stops during the process because only the remaining pressure in the sample collecting container is relied on, it is possible to resume and continue filtration and filter the blood completely through the filter member 4 by using the hollow needle 12 of the jig 11. 15 It is advantageous that filtration can be continued only by attaching the jig 11 to the sample collecting container 1 as described above and the plug member 5 does not need to be detached. Therefore, it ispossible to avoidthepossibilitythat theblood adheres to the operator to cause infection. Furthermore, since 20 the space above the sample collection part 3 will not be opened, contamination by foreign matters will not occur. Fig. 5 is a schematic perspective view showing amodified example of the jig 11. A jig 16 shown in Fig. 5 is not provided with the skirts 14 and 15 shown in Fig. 2. As is the present 25 example, the skirts 14 and 15 are not essential, and the jig 16 16 may consists exclusively of the gripping portion 13 and the hollow needle 12. Furthermore, as the communication needle, only a hollow needle 12A may be used as is the case of the hollow needle 12A 5 shown in Fig. 6. In this case, the hollow needle 12A can be a longer one so that the hollow needle itself can be gripped with a hand and caused to pierce the plug member 5. In the above first embodiment, the hollow needle as explained above is used as a communication needle for allowing 10 communicationbetween the interior and the exterior of the sample collecting container after filtration, however, in the present invention, communication needles other than hollow needles having a hollow flow channel can also be used. Figs. 12Aandl 12Beachrepresent a perspectiveviewshowing 15 a modified example of such communication needles. A communication needle 12B has a communicating groove 12B, extending from its needlepoint to an end opposite to the needlepoint. The communicating groove 12B, serving as a communicating flow channel is formed on the outer periphery of 20 the communication needle 12B and has a generally fan-like cross section. One end of the communicating groove 12B, reaches the needlepoint. Therefore, by using the communication needle 12B inplaceofthehollowneedlel2inthesamplecollectingcontainer 1 used in the first embodiment, for example, it is possible to 25 establish communication between the internal space of the sample 17 collection part and the atmosphere. Accordingly, the communicating groove 12B, does not necessarily reach the end opposite to the needlepoint insofar as it is long enough to establish communication between outside of the plug member 5 5 and inside of the sample collecting container. Acommunicationneedle 12C shown in Fig. 12Bis structured in a similar manner as the communication needle 12B except that the cross section shape of a communicating groove 12CI is generally trapezoidal in the communication needle 12C. The 10 cross section shape of the communicating groove may be arbitrarily changed as described above. Also a communication needle having a plurality of communicating grooves may be used. Fig. 7 is a partially cutaway front section view for 15 explaining a sample collecting container according to a second embodiment of the present invention. In a sample collecting container 51, a cylindrical tube 52 having a bottom is used. Upper part of the tube 52 which constitutes a sample collection part 53 is illustrated. 20 Although omitted in the Fig. 7, a filter member is disposed in a lower part of the sample collection part 53 and a space under the filter member of the tube constitutes a sample storage part. The filter member can be formed of a material similar to those recited in the first embodiment. Also the tube 52 can 25 beformedofamaterialsimilartothoseformingthesamplestorage 18 part 2 and the sample collection part 3 in the first embodiment. Inthesamplecollectingcontaineraccordingtothepresent embodiment, a plug member 55 has a gripping portion 55a and a press-in portion 55b. The press-in portion 55b is designed to 5 hermetically seal an opening 52a of the tube 52. The plug member 55 is formed of an appropriate elastic material such as rubber or elastomer. The plug member 55 is formed with a through hole 55e extending from a top surface 55c to a bottom surface 55d. On 10 the top surface 55c of the plug member 55, a sheet 56 serving as a sealing member is stuck. The sheet 56 is adhered or welded onto the top surface 55c oftheplugmember 55so as tohermetically seal the through hole 55e. The sheet 56 can be formed of any appropriate material such as a laminate of aluminum foil and 15 synthetic resin insofar as hermetical sealing is ensured. On the top surface of the sheet 56, a reinforcing layer 57isstuck. Thereinforcinglayer57 isprovidedforpreventing the sheet 56 from tearing by pressure difference between the internal pressure of the sample collecting container 51 and the 20 atmosphere. Therefore, the reinforcing layer 57 is not necessarily provided when the sheet 56 has enough strength. At one end of the sheet 56 is formed a notch 56a. The notch 56a projects outward than the top surface 55c of the plug member 55. By gripping the notch 56awith a hand, it is possible 25 to easily peel the sheet 56 from the plug member 55. 19 The plug member 55 is usually pressed into an opening at the upper endof the tube 52, however, in theplugmember according to thepresent invention, theplugmemberisnotnecessarypressed in insofar as it can close the opening. For example, the plug 5 member 55 may be formed from a flexible sheet that is attached so as to seal the opening 52a of the tube 52. In this case, a through hole for establishing communication between inside and outside is formed in a part of the sheet-like plug member as described above and the through hole can be sealed with a 10 sealing member attached to the outer surface of the plug member. In the sample collecting container 51, the interior of the tube 52 is depressurized in advance. Therefore, as is of the same with the first embodiment, a samplesuchasbloodcanbecollectedintothesamplecollection 15 part 53byusinga vacuumblood collection needle. Inthepresent case, the vacuumblood collectionneedle pierces the reinforcing layer 57 and extends into the sample collection part 53. Aftercollectionofthesample, thevacuumbloodcollection needle is removed. Then the sample is filtered by a pressure 20 difference between the sample collection part 53 and the space under the filter member disposed below which is not shown in the drawing. Also in the present embodiment, there is a fear that filtration stops during the process when the internal pressure of the tube 52 reaches equilibrium. In the present 25 embodiment, when such a situation occurs, the through hole 55e 20 is allowed to communicate with the atmosphere by picking the notch 56a with fingers and peeling off the sheet 56 from the plug member 55. As a result of this, the space over the filter member is allowed to communicate with the atmosphere, so that 5 filtration resumes by the pressure difference between the downside space and the upside space of the filter member. Thus, filtrationcanalsobesecurelyaccomplishedwithout removing the plug member 55 from the tube 52 when the sample collecting container 51 is used. 10 Fig. 8 is a schematic front section view showing amodified example of the sample collecting container 51. In the sample collecting container 51, the sheet 56 is used as a sealing member for resuming filtration, however, a plug 59 that closes the through hole 55e may also be used. The plug 59 is formed of 15 an elastic material such as rubber or elastomer, and initially pressed into the through hole 55e to hermetically seal the upper endof the throughhole 55e. Incollectinga samplewith a vacuum blood collectionneedle, the center of theplug 59maybepierced, ortheplugmember55maybepiercedwith a vacuumbloodcollection 20 needle in some part other than the part where the plug 59 is provided. Fig. 9 is apartiallycutawayschematic front section view forexplaining a samplecollectingcontaineraccordingto a third embodiment of the present invention. In a sample collecting 25 container 61, a tube 62 having a bottom and an opening 62a at 21 its upper end is used. In the tube 62, a filter member (not illustrated) is located at a middle height position, and the space over the filter member constitutes a sample collection part 63 and the space under the filter member constitutes a sample 5 storage part. A plug member 64 is pressed into the tube so as to hermetically seal the opening 62a at the upper end of the tube 62. The plug member 64 includes a gripping portion 64a and a press-in portion 64b which is smaller in diameter than the 10 gripping portion 64a. The press-in portion 64b is a portion to be pressed into the tube 62. The press-in portion 64b is formed with a recess 64c in a part of the outer periphery. In the tube wall of the tube 62 is formed a through hole 62b that penetrates through the tube 15 wall from inside to outside. The through hole 62b is formed in such a manner that a flow channel that establishes communication between the sample collection part 63 and the atmosphere is formed by the recess 64c when the circumferential position of the recess 64c coincides with that of the through 20 hole 62b. More specifically, in the condition illustrated in Fig. 9, the recess 64c and the through hole 62b are aligned in the circumferentialdirectiontoformtheflowcharnel, howeverthere are initially in different positions. That is, initially the 25 recess 64c is at a position not aligning with the through hole 22 62b so as to keep the depressurized condition in the tube 62. Therefore, as is thecasesof the firstandthe second embodiments using the sample collecting containers 1 and 11, it is possible tocollect a liquidsamplesuchasbloodintothesamplecollection 5 part 63 with a vacuum blood collection needle by utilizing the reduced pressure in the through hole 62b. Then a sample such as blood is filtered by using a filter member in the similar manner as the first and the second embodiments. In this case filtration stops during the process 10 when the pressures of the upside space and the downside space of the filter member reach equilibrium. When such a situation occurs, the plug member 64 is rotated so that the through hole 62b is opposite to the recess 64c as shown in Fig. 9 by shifting theplugmember64circumferentially. Onlywiththisoperation, 15 the flow channel is formed and communication between the sample collection part 63 and the atmosphere is established, so that pressuredifferencegeneratesbetweenthesamplecollectionpart 63 and the sample storage portion under the filter member again to allow progression of filtration. And in the same manner as 20 the case of the first and the second embodiments, filtration of sample is securely completed. Fig. 10 is a partially cutaway front section view of a sample collecting container according to a fourth embodiment of the present invention. A sample collecting container 71 is 25 structured in the same manner as the sample collecting container 23 61 of the third embodiment except for an arrangement for resuming filtration. Therefore, explanation will be given for the parts that are different from those of the third embodiment. In the sample collecting container 71, the through hole 5 62b is provided in the tube 62. On the other hand, a recess 64d is formed in the press-in portion 64b of the plug member 64. The recess 64d is provided at a position lower than the through hole 62b as shown in Fig. 10. Initially, the sample collection part 63 is cut off from the atmosphere because the 10 recess 64d and the through hole 62b are misaligned in the longitudinal direction of the tube 62 as shown in Fig. 10. When the filtration stops during the process because of the operation as described above, the plug member 64 in the state shown in Fig. 10 is slightly drawn out upward. As a result of 15 this, the through hole 62b comes into opposite to the recess 64d, so that the sample collection part 63 is allowed to communicate with the atmosphere. In brief, in the sample collecting container 71, filtration can be resumed by slightly drawing out the plug member 64 upward. 20 Therefore, also in the case of using the sample collecting container 71, the plug member 64 does not need to be detached from the tube 62, so that the operator is less likely to acquire infection through blood and contamination by foreign matters is less likely to occur in the sample collection part 63. 25 Fig. 11 is a schematic front section view for explaining 24 a sample collecting container according to a fifth embodiment of the present invention. In a sample collecting container 81, a sample collection part 83 of cylindrical shape is inserted into a sample storage 5 part82 implementedbyatubehavingabottom. The samplestorage part 82 and the sample collection part 83 are structured in the similar manner as the sample storage part 2 and the sample collectionpart 3 of the first embodiment. Concretely, although not shown in the drawing, a filter member is accommodated in 10 a lower part of the sample collection part 83. And the space under the sample storage part 82 will store a sample having experienced filtration. The plug member 84 includes a gripping portion 84a, a larger-diameter portion 84b and a smaller-diameter portion 84c. 15 The sample storage portion 82 is hermetically sealed by the larger-diameter portion 84b, and an opening at the upper end of the sample collection part 83 is hermetically sealed by the smaller-diameter portion 84c. In the present embodiment, an arrangement that resumes 20 filtrationwhenfiltrationstopsduringtheprocessinthesample collecting container 81 is provided in the plug member 84 and the sample storage part 82. Concretely, a through hole 82b is formed at a position slightly lower than an opening 82a at the upper end of the sample storage part 82. The through hole 82b 25 is formed in a part of inner surface that contacts the 25 larger-diameter portion 84b. On the other hand, the plug member 84 is formed with a flow channel 84e which is open to the outer peripheral surface of the larger-diameter portion 84b at its one end and open to 5 a bottom surface 84d of the plug member 84 at its other end. The vertical position of the opening which is open to the larger-diameter portion 84b in the flow channel 84e generally coincides with that of the through hole 82b of the sample storage part 82. 10 Therefore, when the filtration stops during the process, the sample collection part can be allowed to communicate with the atmosphere by establishing communication between the flow channel 84e and the through hole 82b as shown in the drawing by rotation of the plug member 84. Therefore, filtration can 15 beresumedandfiltrationof a sample such as bloodcanbe securely completed as is the same with the first to the fourth embodiments. Also in this embodiment, blood is less likely to adhere to fingers of the operator during the operation for resuming filtration, and contamination by foreign matters is less likely 20 to occur in the sample collection part. In the sample filtering method using the sample collecting container according to the first embodiment, the sample collecting container 1 having a double tube structure as described above is used, however, the sample filtering method 25 may be applied to the cases where sample collecting containers 26 disclosed in Japanese Unexamined Patent Publication No. 2002-277357, Japanese published Patent No. 3015854, Japanese Unexamined Patent Publication No. 11-290297 (1999), Japanese Unexamined Patent Publication No. 4-20856 (1992) and Japanese 5 Unexamined Patent Publication No. 2001-321365 are used without being limited to the case using the aforementioned sample collecting container. The filtering method of the first embodiment may also be applied to the cases where the sample collecting containers of the second to the fifth embodiments 10 are used. Furthermore, the sample collecting containers according to the second to the fifth embodiments of the invention are featured by an arrangement for resuming filtration as described above, and structures other than this arrangement can be 15 arbitrarilychanged. Forexample, samplecollectingcontainers disclosed in Japanese Unexamined Patent Publication No. 2002-277357, Japanese published Patent No. 3015854, Japanese Unexamined Patent Publication No. 11-290297 (1999), Japanese Unexamined Patent Publication No. 4-20856 (1992) and Japanese 20 Unexamined Patent Publication No. 2001-321365 can also adopt the filtration resuming arrangements according to the second to the fifth embodiments. INDUSTRIAL APPLICABILITY 25 In the sample filtering method using a sample collecting 27 container according to the first aspect of the invention, even when the filtration stops during the process, it is possible to resume filtration by piercing the plug member with a hollow needle to allow communication between the sample collection part 5 and the outside. Therefore, filtration of a liquid sample such as blood can be securely conducted and the plug member does not need to be removed entirely. Therefore, the operator is less likely to be infected through blood and contamination of the sample by foreign matters is less likely to occur. 10 The jig according to the second aspect of the present invention is used to establish communication between inside and outside of a plug member of a sample collecting container and can be used in various aspects. For example, it is suitably used for establishing communication between inside and outside 15 ofthesamplecollectingcontainerinthesample filteringmethod according to the first aspect of the invention. Concretely, only by gripping the jig with a hand via the gripping portion and the skirts andpiercing a plug member of the sample collecting container with a hollow needle, it is possible to establish 20 communication between inside and outside of the plug member. In addition, since the vanes are formed as described above, it is possible to detach the plug member together with the jig from the sample collecting container when detaching the jig. Also in the sample collecting container according to the 25 third aspect of the invention, since filtration is resumed by 28 removal of the sealing member, the operator is less likely to be infected by adhesion of the blood and contamination of the sample by foreign matters is less likely to occur. In the sample collecting container according to the fourth 5 aspect of the invention, filtration is resumed by communication of the through hole provided in the sample collection part and the flow channel provided in the plug member. Therefore, filtration can be resumed without removing the plug member as is the same with the first to the third aspects of the invention. 10 Also in the sample collecting container according to the fifth aspect of the invention, when the plug member is drawn out while keeping hermetical sealing with the inner surface of the sample collection part, the through hole provided in the sample collection part and the flow channel of the plug member 15 are brought into communication with each other. Consequently, filtration can be resumed without detaching the plug member. Therefore, also in the fourth and the fifth aspects of the present invention, filtration can be resumed without detaching the plug member, the operator is less likely to be 20 infectedbyadhesionof thebloodandcontaminationof the sample by foreign matters is less likely to occur. Therefore, according to the first to the fifth aspects of the invention, it is possible to filter a liquid sample safely and reliably. 29

Claims (11)

1. A method for filtering a sample using a sample collecting container that includes: a sample collection part storing a collected liquid sample 5 and having an opening; a plug member provided so as to hermetically seal the opening; a filter member provided in the sample collection part, forfilteringthesamplecollectedinthesamplecollectionpart; 10 and a sample storage part for storing a sample filtered by the filter member, the internal pressure thereof being reduced in advance, wherein after collecting a sample in the sample collection 15 part using a vacuum blood collection needle, the sample is filteredby apressure difference between the sample collection part and the sample storage part, while the plugmember is pierced by a communication needle having a communication flow channel to establish communication between the sample collection part 20 and the exterior, thereby elevating the internal pressure of the sample collection part.
2. The method for filtering a sample according to claim 1, wherein the communication needle is a hollow needle. 25 30
3. The method for filtering a sample according to claim 1, wherein the communication needle has a communication groove formed on its outer surface and the communication groove extends from a needlepoint toward an end opposite to the needlepoint. 5
4. A jig for collecting a sample used for communicating the interior and the exterior of a sample collecting container that includes a samplecollectionpartstoring a collectedliquid sample and having an opening, and a plug member provided so as 10 to hermetically seal the opening, the jig comprising: a communication needle having a communication flow channel extending from the sideof a needlepoint to the otherendopposite to the needlepoint; a gripping portion attached to the side of the other end of the communication needle; a skirt portion 15 extending in the axial direction of the communication needle from the gripping portion; and at least one vane provided on the side of the needlepoint of the communication needle.
5. The method of filtering a sample according to claim 20 4, wherein the communication needle is a hollow needle.
6. The method of filtering a sample according to claim 4, wherein the communication needle has a communication groove formed on its outer surface and the communication groove extends 25 from a needlepoint toward an end opposite to the needlepoint. 31
7. Asample collecting container that enables filtration of a liquid sample, comprising: a sample collection part having an opening and storing 5 a collected liquid sample; a plug member provided so as to hermetically seal the opening; a filter member provided in the sample collection part, forfilteringthesamplecollectedinthesamplecollectionpart; 10 and a sample storage part for storing the sample filtered by the filter member, the sample collection part, the filter member and the sample storagepartbeinghermeticallyconnectedwitheachother 15 and the internal pressure of sample storage part being reduced in advance, wherein the plugmemberhas athroughhole that establishes communication between the sample collection part the exterior, andthethroughholeishermeticallysealedby a removablesealing 20 member on the outer surface of the plug member.
8. The sample collecting container according to claim 7, wherein the sealing member is a sheet affixed to the outer surface of the plug member so as to cover the outer surface where 25 the through hole of the plug member is open. 32
9. The sample collecting container according to claim 7, wherein the sealing member is a plug press-fitted into the through hole. 5
10. Asamplecollectingcontainerthatenablesfiltration of a liquid sample, comprising: a sample collection part having an opening and storing a collected liquid sample; 10 aplugmemberpressed into the opening so as to hermetically seal the opening; a filter member provided in the sample collection part, for filteringthesamplecollectedinthesamplecollectionpart; and 15 a sample storage part for storing the sample filtered by the filter member, the sample collection part, the filter member and the sample storagepartbeing hermetically connectedwith each other and the internal pressure of sample storage part being reduced 20 in advance, wherein an open through hole is formed in a part of inner surface of the sample collection part that is in contact with the plug member, and a flow channel is formed in a part of outer surface of the plug member contacting the inner surface of the 25 sample collection part, the flow channel establishing 33 communication between the through hole and the interior of the sample collection part when its circumferential position is brought into coincidence with the through hole. 5
11. Asamplecollectingcontainerthatenablesfiltration of a liquid sample, comprising: a sample collection part having an opening and storing a collected liquid sample; a plug member provided so as to hermetically seal the 10 opening; a filter member provided in the sample collection part, for filtering the sample collected in the sample collection part; and a sample storage part for storing a sample filtered by 15 the filter member, the sample collection part, the filter member and the sample storage partbeing hermetically connectedwith each other and the internal pressure of sample storage part being reduced in advance, 20 wherein an open through hole is formed in a part of inner surface of the sample collection part that is in contact with the plug member, and a flow channel is formed in the plug member in such a manner that when the plug member is drawn out from the sample collection part while keeping hermetical sealing 25 between the plug member and the inner surface of the sample 34 collection part, one end of the flow channel is opposite to the through hole and the other end of the flow channel is open in the sample collection part. 35
AU2004233677A 2003-04-25 2004-04-22 Method and tool for filtrating specimen using specimen sampling container, and specimen sampling container Abandoned AU2004233677A1 (en)

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US7767466B2 (en) 2010-08-03
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EP1618845A1 (en) 2006-01-25
EP1618845A4 (en) 2010-12-01
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WO2004096046A1 (en) 2004-11-11
CN1780583A (en) 2006-05-31

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